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amphotericin B (Ampholip)

✓ Approved

Bharat Serums and Vaccines Limited · 小分子 · 小分子

什么是 amphotericin B？

amphotericin B 是一种小分子，由Bharat Serums and Vaccines Limited研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名Ampholip
公司Bharat Serums and Vaccines Limited
药物类别小分子
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Bharat Serums and Vaccines Limited

治疗适应症

amphotericin B 针对 3 个适应症，涉及 2 个治疗领域。

治疗领域疾病/病症分期
Cardiac disordersEndocardial disease✓ Approved
Infections and infestationsCandida infection✓ Approved
Infections and infestationsAspergillus infection✓ Approved

相关研究文献

PubMedJournal of fungi (Basel, Switzerland)2026-07-27

In Vitro Anti-Aspergillus Activity and Antifungal Interactions of Monoclonal Antibodies 1D2 and 4E4.

Lian Xihua X, Scott-Thomas Amy A, Lewis John G JG, Bhatia Madhav M et al.

To determine the in vitro anti-Aspergillus activity of monoclonal antibodies (mAb) 1D2 and 4E4 alone and in combination with voriconazole, posaconazole, amphotericin B and caspofungin and to assess whether selected antimicrobial agents interfere with 1D2/4E4 binding to Aspergillus antigens. The in vitro antifungal activity of 1D2, 4E4 and all antifungal drugs was determined in a microplate-based assay. The anti-Aspergillus activity of mAb 1D2 and 4E4 in vitro alone and in combination with voriconazole, posaconazole, amphotericin B and caspofungin was determined using a checkerboard assay. Finally, a competitive ELISA was used to assess whether selected antifungal and antibacterial agents interfered with the binding of 1D2 and 4E4 to immobilised Aspergillus antigens. The in vitro interactions of 1D2 with voriconazole, posaconazole, amphotericin B and caspofungin against four different Aspergillus species were all additive, with a fractional inhibitory concentration index (FICI) between 0.5 and 1. Similarly, the in vitro interactions of 4E4 with these same four antifungals against Aspergillus fumigatus (A. fumigatus) were all additive. An additive interaction was also detected for 4E4 and caspofungin against all four Aspergillus species tested. However, no interaction was found for 4E4 combined with voriconazole, posaconazole and amphotericin B against Aspergillus flavus (A. flavus), Aspergillus niger (A. niger) and Aspergillus terreus (A. terreus), with an FICI between 1 and 4. Moreover, none of the tested antifungal or antibacterial agents significantly interfered with 1D2/4E4 binding to Aspergillus antigens in the competitive ELISA. In this study, 1D2 and 4E4 showed in vitro growth-inhibitory activity against the tested Aspergillus isolates. Specifically, 1D2 showed additive interactions with the tested antifungal agents across all tested species, whereas 4E4 showed a more species- and drug-dependent interaction profile. The tested antimicrobial agents did not measurably interfere with 1D2/4E4 binding under the competitive ELISA conditions examined. Overall, these findings provide preliminary in vitro evidence supporting the further evaluation of 1D2 and 4E4.

PMID 42506284
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PubMedJournal of fungi (Basel, Switzerland)2026-07-27

Rhino-Orbital Mucormycosis Following COVID-19 Viral Vector Vaccination in an Immunocompetent Patient.

Strianese Diego D, Troisi Mario M, Iuliano Adriana A, Cohen Dana D et al.

Rhino-orbital mucormycosis is a rare, life-threatening opportunistic fungal infection, typically affecting immunocompromised patients. During the COVID-19 pandemic, increased cases were mainly linked to SARS-CoV-2 infection, diabetes, and corticosteroid exposure. We report a severe case in a previously healthy 44-year-old immunocompetent man who developed acute left-sided exophthalmos, ophthalmoplegia, severe visual loss, and systemic deterioration 10 days after AZD1222 COVID-19 vaccination. Clinical and radiologic findings suggested invasive rhino-orbital fungal disease, prompting immediate liposomal amphotericin B, broad-spectrum antibiotics, urgent endoscopic sinus surgery, and repeated orbital-sinonasal debridements with amphotericin B irrigation. Histopathological examination demonstrated broad aseptate hyphae with tissue necrosis, consistent with mucormycosis, while fungal culture and ITS sequencing identified Rhizopus arrhizus as the causative species. Therapy was later adjusted to include isavuconazole and antibacterial coverage for persistent inflammation and secondary colonization. Orbital and systemic improvement occurred within the first week, with globe preservation and marked proptosis reduction at 6 months, despite persistent ophthalmoplegia and residual light perception. Isavuconazole was continued for 2 years, with no recurrence during 3 years of follow-up. Although causality with vaccination cannot be established, the temporal association and biological plausibility warrant further investigation. Early suspicion and prompt combined medical-surgical management are essential in rapidly progressive orbital cellulitis.

PMID 42506277
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PubMedJournal of fungi (Basel, Switzerland)2026-07-27

Non-Interventional, Retrospective, Multicenter Study on the Renal Safety of Liposomal Amphotericin B in Critically Ill Patients with Invasive Pulmonary Aspergillosis.

Suberviola Borja B, Ceballos Jose Peral Gutierrez de JPG, Martin Maria Jose Asensio MJA, Soriano Cuesta Cruz C et al.

Purpose: This study aims to determine the incidence of kidney injury associated with liposomal amphotericin B (L-AmB) treatment, based on RIFLE criteria, in patients admitted to the intensive care unit (ICU) with invasive pulmonary aspergillosis (IPA). Materials and Methods: A retrospective, multicenter observational study including patients treated with L-AmB for IPA while admitted to the ICU between 1 January 2015, and 31 December 2022. Results: A total of 65 patients were included. The prevalence of renal failure was 35.39%. Renal failure was mostly mild and reversible. The need for major surgery (OR 6.71; p = 0.121) and concomitant use of other nephrotoxic treatments (OR 2.5; p = 0.194) emerged as potential risk factors for the development of renal failure; however, neither association reached statistical significance. Overall mortality was 66.2%, significantly higher in the group with renal failure (82.6% vs. 57.1%; p = 0.03). Factors associated with mortality included concomitant use of other nephrotoxic agents (OR 4.51; p = 0.024) and development of renal failure (OR 3.66; p = 0.068). Duration of L-AmB treatment was not associated with mortality. Regarding creatinine recovery, all patients who developed renal failure but survived showed creatinine levels below 1.5 mg/dL after completion of treatment. Conclusions: Renal impairment was common in this high-risk population of critically ill patients, with renal function impairment in one-third of exposed patients, although most cases were mild. In this population, concomitant administration of other nephrotoxic drugs was associated with both renal failure and mortality. Treatment duration with L-AmB was not linked to mortality, and creatinine levels normalized after therapy completion.

PMID 42506220
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PubMedCureus2026-07-27

Pulmonary Cryptococcosis With Suspected Central Nervous System Involvement in a Patient With Sarcoidosis and CD4 Lymphopenia: A Case Report.

Almaradweh Sara S, Gul Zonaira Z

Sarcoidosis is a multisystem granulomatous disorder associated with immune dysregulation and impaired cell-mediated immunity, which may increase susceptibility to opportunistic infections, including cryptococcosis. The clinical and radiological overlap between sarcoidosis progression, neurosarcoidosis, and cryptococcal infection can create a significant diagnostic challenge, particularly when neurological symptoms are present. We present a 50-year-old male with a 15-year history of pulmonary sarcoidosis and CD4 lymphopenia who developed pulmonary cryptococcosis with subsequent symptoms concerning for central nervous system (CNS) involvement after self-discontinuation of antifungal therapy. His clinical course was notable for neck stiffness, photophobia, headaches, cognitive slowing, positive serum cryptococcal antigen testing, bronchoscopy confirming Cryptococcus species, and recurrent herpes zoster, suggesting impaired cell-mediated immunity. Cerebrospinal fluid culture showed no growth after antifungal therapy had already been initiated, and CNS involvement was considered clinically suspected rather than microbiologically confirmed. Treatment was complicated by acute kidney injury attributed in part to amphotericin B-associated nephrotoxicity, requiring transition to fluconazole consolidation therapy. This case underscores the importance of maintaining a high index of suspicion for opportunistic infections in patients with sarcoidosis who develop atypical, progressive, or neurological manifestations. Early cerebrospinal fluid evaluation, including cryptococcal antigen testing when clinically indicated, and careful infectious disease assessment before escalation of immunosuppressive therapy are essential to avoid diagnostic delay and guide appropriate treatment.

PMID 42504350
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PubMedAntibiotics (Basel, Switzerland)2026-07-27

Changes in Antimicrobial Resistance Patterns in Intensive Care Units Following the COVID-19 Pandemic: A 10-Year Retrospective Study from Türkiye.

Çapar Ayşe A, Özyiğitoğlu Derya D, Başlılar Şeyma Ş, Efil Erdoğan Mürşide M et al.

The coronavirus disease 2019 (COVID-19) pandemic coincided with substantial changes in healthcare delivery and antimicrobial resistance (AMR) patterns worldwide, particularly in intensive care units (ICUs), where invasive procedures and broad-spectrum antibiotics are commonly used. Data from Türkiye remains limited. This retrospective observational study evaluated bacterial and fungal isolates from adult ICU patients at a tertiary hospital from 2016 to 2025. Microorganisms were identified, and antimicrobial susceptibility testing was performed using standardized methods. Resistance patterns were compared between the pre-pandemic (January 2016-February 2020) and post-pandemic (March 2020-May 2025) periods. A total of 2666 patients and 5433 isolates were analyzed. Gram-negative pathogens showed marked increases in resistance: carbapenem and colistin resistance in Klebsiella pneumoniae were significantly higher in the post-pandemic period (69.6% vs. 44.4% and 60.5% vs. 22.5%, respectively; p < 0.001). Resistance rates to multiple antimicrobial agents also increased in Acinetobacter baumannii and Pseudomonas aeruginosa (p < 0.05). Among Gram-positive bacteria, vancomycin-resistant Enterococcus faecium increased from 10% to 47.1%. Candida auris emerged only in the post-pandemic period, showing high resistance to fluconazole (75%) and amphotericin B (36.7%). Significant differences in AMR patterns were observed between the pre- and post-pandemic periods in this ICU population. Higher resistance rates were observed among several clinically important bacterial pathogens, and Candida auris emerged exclusively during the post-pandemic period. Given the study's observational design, these findings should be interpreted as temporal associations rather than evidence of a causal effect of the COVID-19 pandemic. Continued antimicrobial stewardship and infection-control measures remain essential to address the growing burden of AMR.

PMID 42505599
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PubMedBritish journal of clinical pharmacology2026-07-27

HLA-B*15:21 carrier status is a susceptibility factor of carbamazepine-induced nonimmediate cutaneous adverse reactions in HLA-B*15:02-negative patients: A retrospective cohort study.

Ruanglertboon Warit W, Seree-Aphinan Chutima C, Sangiemchoey Antida A, Kaewpiboon Khwanchanok K et al.

Pre-prescription HLA-B*15:02 screening is a standard practice to prevent carbamazepine (CBZ)-induced nonimmediate cutaneous adverse reactions (cADR) in Asian populations. However, HLA-B*15:11 and HLA-B*15:21 also increase susceptibility of CBZ-induced cADR, but its influence on the residual risk after HLA-B*15:02 screening remains limited. This study aimed to evaluate the residual risk and the nature of cADR following HLA-B*15:02 screening in a region with high HLA-B diversity. We retrospectively reviewed HLA-B*15:02-screened cases at Songklanagarind Hospital, Thailand. HLA-B*15:02-negative cases were assessed for CBZ prescription history, follow-up history and treatment outcomes. HLA-B*15:11 and HLA-B*15:21 carrier status of HLA-B*15:02-negative cases who took CBZ was re-evaluated using a quantitative PCR, sanger sequencing and HLA typing method. Patients who received CBZ and those with confirmed CBZ-induced nonimmediate cADR were used to calculate residual risk and genetic association. Among 560 HLA-B*15:02-negative cases, 288 received CBZ. The carrier frequency of HLA-B*15:11 and HLA-B*15:21 were 6.9% (20/288). CBZ-induced nonimmediate cADRs were confirmed in 17 cases, translating to a residual risk of 0.059. The cADRs were observed in 20.0% (4/20) of HLA-B*15:11 or HLA-B*15:21 carriers (all four cases were HLA-B*15:21 carriers) compared to 4.85% (13/268) of non-carriers. Firth's penalized logistic regression suggested that HLA-B*15:21 increases odds of CBZ-induced nonimmediate cADR (OR 5.84, 95% CI 1.58-19.07; p = .010). This report provided the first real-world evidence of residual risk of CBZ-induced cADR after screening negative for HLA-B*15:02 that associated with other HLA-B markers. Therefore, incorporating a broader screening may further enhance drug safety in populations with a diverse HLA-B admixture.

PMID 42504015
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